FDA.reportPublic FDA data

NORTRIPTYLINE HYDROCHLORIDE

Product NDC
61919-353
11-digit product format
619190353
Labeler code
61919
Product ID
61919-353_fb483e5f-a6cf-3d2b-e053-6294a90af03f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NORTRIPTYLINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA075520
Marketing category
ANDA
Marketing start
2021-09-15
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NORTRIPTYLINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198046

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
53e88688-54e1-9681-22b8-e499bd715088Product name220210729
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-353-302025-01-30C16284748780-11030e365-692b-111a-e063-dadaa90a10e2NORTRIPTYLINE HYDROCHLORIDE
61919-353-602025-01-30C16284748780-11030e365-692b-111a-e063-dadaa90a10e2NORTRIPTYLINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-353-30NORTRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE305
61919-353-60NORTRIPTYLINE HYDROCHLORIDE60 in 1 BOTTLECAPSULE605
61919-353-90NORTRIPTYLINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-353NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]4Current NDC, Legacy NDC, 3 package rows20210918_45884cad-4a2d-44f4-93bd-16b130daf32d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198046nortriptyline HCl 50 MG Oral CapsulePSN45884cad-4a2d-44f4-93bd-16b130daf32d5
198046nortriptyline 50 MG Oral CapsuleSCD45884cad-4a2d-44f4-93bd-16b130daf32d5
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSY45884cad-4a2d-44f4-93bd-16b130daf32d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-353-306191903533030 CAPSULE in 1 BOTTLE (61919-353-30) 30 capsule2021-09-150000-00-00NoNoCurrent
61919-353-606191903536060 CAPSULE in 1 BOTTLE (61919-353-60) 60 capsule2021-09-150000-00-00NoNoCurrent
61919-353-906191903539090 CAPSULE in 1 BOTTLE (61919-353-90) 90 capsule2021-09-15NoNoCurrent